HIV Infection Clinical Trial
Official title:
A Phase II Trial of COL-3 in Patients With HIV Related Kaposi's Sarcoma
COL-3 may stop the growth of cancer by stopping blood flow to the tumor. Randomized phase II trial to compare the effectiveness of two different regimens of COL-3 in treating patients who have HIV-related Kaposi's sarcoma.
PRIMARY OBJECTIVES:
I. To evaluate the tumor response rate and response duration of treatment with Col-3 at two
different dose levels- 50 mg/day and 100 mg/day in subjects with HIV related KS.
II. To evaluate the biologic activity of Col-3 by measuring percent apoptotic cells on tumor
biopsies pre- and post-treatment.
III. To evaluate the effect of Col-3 on serum levels of MMP-2 and MMP-9.
SECONDARY OBJECTIVES:
I. To determine the safety and toxicity of Col-3 at two different dose levels in HIV related
KS.
II. To evaluate the effect of Col-3 on overall quality of life. III. To evaluate the
relationship between clinical response and quantitative measures of KSHV/HHV-8 and HIV viral
load.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of
2 treatment arms.
Arm I: Patients receive low-dose oral COL-3 once daily.
Arm II: Patients receive high-dose oral COL-3 once daily.
Treatment on both arms continues in the absence of disease progression or unacceptable
toxicity. Quality of life is assessed.
Patients are followed for at least 1 month.
PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this
study within 1.75 years.
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